NewG Lab-NewG Lab Pharma Selected as Clinical CRO for Anticancer Agent KAT Trial

[Asia Economy Reporter Hyunseok Yoo] Newgelab announced on the 2nd that its U.S. subsidiary Newgelab Pharma, which is developing the next-generation anti-cancer agent KAT (Ko Anti-cancer technology), has selected Premier Research as its clinical trial contract research organization (CRO).

KAT is an anti-cancer drug candidate developed based on the Warburg effect theory, which won the Nobel Prize in Physiology or Medicine in 1931. The Warburg effect is a theory that cancer cells generate ATP (adenosine triphosphate), an energy source, through glycolysis, unlike normal cells that obtain energy through oxygen.

KAT is a new drug candidate being developed as an API (active pharmaceutical ingredient) containing the substance ‘3BP’, which inhibits ATP production by blocking both anaerobic and aerobic respiration in cancer cells. Various in vitro and in vivo experiments conducted by the U.S. National Cancer Institute and others have shown consistent anti-cancer effects across different cancer types, and preclinical animal studies conducted with Covance have been successfully completed.

Newgelab Pharma has completed all preparations for the global clinical trials of KAT and selected Premier Research, headquartered in the U.S., as its clinical trial partner.

Premier Research, established in 1989 and headquartered in the U.S., is a specialized CRO for biotech clinical trials. It employs 1,600 staff across 84 countries worldwide and is recognized as a global top-tier organization. It received the ‘CRO Leadership Award’ from Life Science Leader, a U.S. life sciences industry publication, in 2018 and 2020.

A Newgelab representative stated, “KAT research has been conducted with the industry’s top partners at each stage,” adding, “The clinical trial drugs are also being smoothly prepared by CDMOs in the U.S. and the U.K.”

He continued, “Premier Research, selected as the clinical trial CRO this time, is an institution with strengths in oncology and rare disease approvals,” and added, “It is the most suitable organization to conduct KAT’s clinical trials.”

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